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Nutropin GPS™ and Patient Support

Get personalized help from Nutropin Growing Patient Support (GPS) Program

Whether it's getting your treatment up and running quickly, helping to navigate the insurance maze, or getting your growth hormone (GH) therapy questions answered, Nutropin GPS has an ongoing commitment to support you and your healthcare team throughout treatment.

Dedicated Case Manager

Getting Started with Nutropin GPS™

First things first:

To let us help you access your prescribed Nutropin therapy and our patient support programs, provide your approval with the online Patient Authorization and Notice of Release of Information (PAN) form.

How do I get started?

Your doctor’s office will send a statement of medical necessity (SMN) and a prescription to a specialty pharmacy (a pharmacy that specializes in filling prescriptions for complex conditions) and to your insurance company. If you and your doctor decide to use Nutropin GPS services, you'll be assigned a case manager. Your case manager will work with you to make sure you receive the medication and injection training you need to start therapy.

What does my case manager do?

When you or your doctor's office calls Nutropin GPS, we'll connect you with a dedicated Nutropin GPS case manager who can try to help you with issues such as:

By using the Nutropin GPS™ Co-pay Card Program, the patient acknowledges and confirms that, at the time of usage, (s)he is currently eligible and meets the criteria set forth in the terms and conditions described.

This Co-pay Card is valid ONLY for patients with commercial (private or non-governmental) insurance who are taking the medication for a Food and Drug Administration (FDA)-approved indication. Patients using Medicare, Medicaid, or any other government-funded program to pay for their medications are not eligible. Patients who start utilizing their government coverage during their enrollment period will no longer be eligible for the program.

This Co-pay Card Program is not health insurance or a benefit plan. Distribution or use of the Co-pay Card does not obligate use or continuing use of any specific product or provider. Patient or guardian is responsible for reporting the receipt of all Co-pay Card Program benefits or reimbursement received to any insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-pay Card Program, as may be required.

The Co-pay Card is not valid for medications the patient receives for free or that are eligible to be reimbursed by private insurance plans or other healthcare or pharmaceutical assistance programs (such as Genentech® Access to Care Foundation (GATCF) or any other charitable organization) that reimburse the patient in part or for the entire cost of his/her Genentech medication. Patient, guardian, pharmacist, prescriber, and any other person using the Co-pay Card agree not to seek reimbursement for all or any part of the benefit received by the recipient through the offer.

The Co-pay Card will be accepted by participating pharmacies, physician offices, or hospitals. To qualify for the benefits of this Co-pay Card Program, the patient may be required to pay out-of-pocket expenses for each treatment. Once enrolled, this Co-pay Card Program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 120 days. This Co-pay Card is only available with a valid prescription and cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription. Use of this Co-pay Card must be consistent with all relevant health insurance requirements and payer agreements. Participating patients, pharmacies, physician offices, and hospitals are obligated to inform third-party payers about the use of the Co-pay Card as provided for under the applicable insurance or as otherwise required by contract or law. The Co-pay Card may not be sold, purchased, traded, or offered for sale, purchase, or trade. The Co-pay Card is limited to 1 per person during this offer period and is not transferable. This program expires within 12 months from enrollment. This program is not valid where prohibited by law. For Massachusetts residents, the Co-pay Card is not valid for any prescription drug that has an AB-rated generic equivalent as determined by the FDA. For Massachusetts residents, this program shall expire on or before July 1, 2019.

The patient or their guardian must be 18 years or older to receive Co-pay Card Program assistance. This Co-pay Card Program is (1) void if the card is reproduced; (2) void where prohibited by law; (3) only valid in the United States and Puerto Rico; and (4) only valid for Genentech products. Healthcare providers may not advertise or otherwise use the program as a means of promoting their services or Genentech’s products to patients. Genentech reserves the right to rescind, revoke, or amend the program without notice at any time.

Can I receive assistance while I wait for insurance approval?NuAccessSM Program

We know the process for insurance verification and authorization takes time. Eligible patients may receive medicine for a limited time while their insurance coverage is being evaluated. To learn how to get started, read Getting Started with Nutropin GPS.

What other co-pay support options are available to me?Independent Co-pay Assistance Program*

For those who don't qualify for the Nutropin GPS Co-pay Card Program, we can also refer you to a co-pay foundation for help with your co-pay. You may be referred to a co-pay assistance program if you have:

Public insurance, such as Medicare or Medicaid

Private insurance

Patients enrolled in Medicare Part D may be eligible to apply for co-pay assistance, including fees associated with true out-of-pocket (TrOOP) expenses.

*Genentech and Nutropin GPS™ do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from Nutropin GPS™. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s or Nutropin GPS™ endorsement or financial support. There may be other foundations to support the patient's disease state.

I have no insurance, or Nutropin is not covered by my plan. Can you help?Genentech® Access To Care Foundation (GATCF)

The Genentech® Access to Care Foundation, or GATCF, can help you receive Nutropin free of charge, if you qualify.

GATCF helps people who don't have health insurance. It also helps people who have health insurance but have trouble paying for Nutropin. If you qualify for GATCF, you could receive Nutropin free of charge.

Eligibility Criteria

INSURANCE

FINANCIAL

MEDICAL

Patient is without coverage for Genentech medicine(uninsured or rendered uninsured by payer denial)

Patient annual household adjusted gross income (AGI) is ≤$100,000 or Patient annual household AGI is >$100,000–≤$150,000 and the out-of-pocket (OOP) costs for his or her Genentech medicines account for ≥5% of his or her annual household AGI

Patient must be prescribed a
Genentech medicine and meet certain medical criteria as established by an independent advisory board

Patient has coverage for Genentech medicine(insured)

Patient annual household AGI is ≤$150,000 and the OOP costs for his or her Genentech medicines account for ≥5% of his or her annual household AGI, and all patient assistance options have been exhausted, including Genentech brand-specific co-pay cards and support from co-pay assistance foundations supporting the patient’s disease state

To be eligible for free medicine from GATCF, insured patients must have exhausted all other forms of patient assistance (including Genentech brand-specific co-pay cards and support from independent co-pay assistance foundations) and meet additional criteria.

To get started with GATCF, complete and submit the Statement of Medical Necessity (SMN) and Patient Authorization and Notice of Release of Information (PAN) to Genentech Access Solutions.

Once we receive your patient’s information, Genentech Access Solutions will contact you with further instructions. This may include verifying financial eligibility.

IMPORTANT SAFETY INFORMATION

Nutropin therapy and your safety:

Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor.

NUTROPIN THERAPY IS NOT FOR:

Patients having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life-threatening breathing problems. Deaths have been reported in such cases

Children who have Prader-Willi syndrome (PWS) and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with PWS who are very overweight, have a history of blocked upper airways, sleep apnea (pauses in breathing during sleeping), or other severe breathing problems

Patients who have active cancer. Because growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland, the presence of these types of tumors should be ruled out by your doctor before you start Nutropin therapy

Patients who are allergic to somatropin, the active ingredient in Nutropin therapy, or the inactive ingredients in Nutropin therapy

Adults or children with certain types of eye disease caused by diabetes

Children and teenagers whose bones have finished growing

What should you tell your doctor before starting Nutropin therapy?

If you take cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted during Nutropin therapy

If you had cancer as a child. An increased risk of a new tumor, particularly certain brain tumors, has been reported in patients taking Nutropin therapy. If you have pre-existing tumors or growth hormone deficiency caused by abnormal tissue in the brain, you should be watched closely for the worsening or return of this condition

If you have diabetes, risk factors for diabetes, or impaired glucose tolerance. If so, your doctor should monitor your blood sugar closely during Nutropin therapy. New cases of type 2 diabetes have been reported in patients taking Nutropin therapy

If you have pituitary hormone deficiency(s) (an inability of the pituitary gland to produce sufficient hormones) or adrenal hormone deficiency (an inability of the adrenal glands to produce sufficient hormones, primarily cortisol). Your doctor may further monitor your hormone levels or your hormone replacement therapy closely while you are taking Nutropin therapy

If you are pregnant, nursing, or plan to become pregnant. It is not known whether Nutropin is excreted in human milk. Nutropin therapy should be used during pregnancy only when clearly needed

While taking Nutropin, contact your doctor immediately if you experience:

Changes in upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, in patients with PWS. These patients should also have effective weight control and be monitored by a doctor for signs of respiratory infection

Changes in vision, a bad headache, or nausea with or without vomiting. This may be a sign of increased pressure in the brain

Any allergic reaction you experience to the injection of Nutropin therapy

A limp or have hip or knee pain

A fracture in the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth

Children with growth failure due to CKD should be examined periodically for evidence of loss of bone minerals. Hip x-rays should be taken before starting Nutropin therapy in these children

Progression of scoliosis (curvature of the spine) that can occur in children who have rapid growth. Nutropin therapy has not been shown to increase the occurrence of this condition

Abdominal pain. Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving Nutropin therapy

Other important information about Nutropin

Adults may retain water during Nutropin therapy. This may be brief but may increase with higher doses of Nutropin therapy

Patients should have their thyroid function tested periodically during Nutropin therapy. Thyroid hormone treatment may need to be started or adjusted

Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the first injection

The use of Nutropin therapy has not been studied in patients over 65 years of age. Elderly patients may be more sensitive to Nutropin therapy and may experience more side effects

Patients with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems during Nutropin therapy

What are common possible side effects of Nutropin therapy?

Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do not freeze. Cartridges and NuSpin pens must be used within 28 days of initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the cartridge or pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

INDICATIONS:

WHO IS NUTROPIN THERAPY FOR?

Nutropin AQ® (somatropin) injection for subcutaneous use is a human growth hormone that is available by prescription only.

Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

Do not make enough growth hormone on their own

Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found

Have Turner syndrome

Have chronic kidney disease (CKD) up to the time of kidney transplant

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or

Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy